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Wednesday 21st August 2019

NICE gives green light to romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP)

17th March 2011

The National Institute for Health and Clinical Excellence (NICE) has recommended romiplostim (Nplate, Amgen) for the treatment of chronic immune (idiopathic[1]) thrombocytopenic purpura (ITP) in some patients in draft guidance issued today (Thursday 17 March 2011).

ITP is a bleeding disorder in which the immune system destroys platelets, which are needed for normal blood clotting. People with the disease have abnormally low levels of platelets in the blood. The condition is currently thought to affect 3000 - 3500 people in the UK; some patients may only have the condition for a short period of time, but when a patient has ITP for over 12 months this is defined as having chronic ITP.

In this draft guidance, romiplostim is recommended for the treatment of adults with chronic ITP:

  • whose condition does not respond to standard active treatments and rescue therapies or,
  • who have severe disease, and a high risk of bleeding that requires frequent courses of rescue therapies, and
  • if the manufacturer makes romiplostim available with the rebate on the list price agreed under the patient access scheme.

Only a haematologist should initiate and supervise treatment with romiplostim. The recommendations are conditional on the manufacturer providing romiplostim at a discounted cost as part of a patient access scheme[2].

NICE has not yet issued final guidance to the NHS; consultees now have the opportunity to appeal against this final draft guidance.

Dr Carole Longson, Director, Health Technology Evaluation Centre at NICE said: “ITP is a serious, sometimes debilitating disorder, and some of the current treatments have considerable side effects, so we are pleased to recommend the use of romiplostim as a clinically and cost effective treatment for some people with severe, chronic ITP in our draft guidance issued today. The manufacturer has also submitted a patient access scheme where the cost of the treatment will be reduced.”

The draft guidance is available from Thursday 17 March until Thursday 31 March.

Consultees now have the opportunity to appeal against this draft guidance. If there are no appeals, or an appeal is not upheld, the recommendations in the draft will be issued as final NICE guidance. NICE expects to issue final guidance to the NHS in April 2011. Until this time, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

Final guidance is likely to be published in April 2011.

[1] Of unknown cause.
[2] Patient access schemes are ways pharmaceutical companies can propose to enable patients to gain access to high cost drugs.

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